Protocol Number: 01-C-0125
Transplantation of donated stem cells (cells produced by the bone marrow that mature into white and red blood cells and platelets) is a very effective treatment for patients with leukemia, pre-leukemia and lymphoma. However, despite its success in a large number of patients, this procedure has many serious side effects and carries a significant risk of death. These complications result from the intensive chemotherapy and radiation patients receive before the transplant to rid the body of cancer cells. In this study, radiation will not be used and chemotherapy drugs will be given in lower doses to try to reduce the dangers of the procedure. Patients between 5 and 21 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplasia, chronic myelogenous leukemia, juvenile chronic myelogenous or myelomonocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests (including testing for genetic match with the donor), breathing tests, X-rays, scans and other tests to determine eligibility. They may also undergo bone marrow aspiration, in which the hip area is anesthetized and a small sample of bone marrow is drawn through a needle inserted into the hipbone. A spinal tap may be done to look for cancer cells in the central nervous system. This procedure involves numbing the back and inserting a needle between the bones of the spine to withdraw a small amount of spinal fluid. A central venous catheter (flexible plastic tube placed in a vein) will be put in place before treatment begins. It will be used to draw and transfuse blood, give medications, and infuse the donated stem cells. Before the transplant procedure, patients will receive induction chemotherapy with cyclophosphamide, fludarabine, etoposide, doxorubicin, vincristine and prednisone for 4 days, followed by a 17-day rest period. No more than 3 cycles of this chemotherapy will be given. Following the induction chemotherapy, patients will be admitted to the Clinical Center for 4 days of chemotherapy with cyclophosphamide and fludarabine. The donated stem cells will be infused 3 days later. Patients can leave the hospital when their white cell counts return to near normal and they have no serious complications. After discharge, they will be followed closely (at least once or twice weekly for the first 100 days after transplant) with a physical exam and blood tests. Patients may require immunoglobulin or antibiotics to fight infections and transfusions of red blood cells and platelets. After the 100 days, follow-up visits will continue less frequently for at least 5 years.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/17/2008
|
||